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Part A-800 mg NST-6179 for Intestinal Failure Associated Liver Disease

Phase 2

Recruiting

Research Sponsored by NorthSea Therapeutics B.V.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total bilirubin ≤2.0 mg/dL in the absence of Gilbert's Syndrome.

Key

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 14

Awards & highlights

Study Summary

This trial will study the safety, effectiveness, and how the body processes a new drug for intestinal failure-associated liver disease. Up to 36 adults will be enrolled, with 18 in each part of the study taking either the drug or placebo.

Who is the study for?

Adults over 18 with Intestinal Failure-Associated Liver Disease (IFALD) who have been on parenteral nutrition for at least 6 months can join. They must have certain liver enzyme levels above normal or high bilirubin, but not too high, and meet other blood test criteria.Check my eligibility

What is being tested?

The trial is testing NST-6179's safety and effects in two parts: Part A gives a daily oral dose of either the drug or placebo for four weeks; Part B may increase the dose for twelve weeks based on earlier results.See study design

What are the potential side effects?

Specific side effects are not listed here, but generally, participants will be monitored for any adverse reactions to NST-6179 compared to those taking a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My total bilirubin level is 2.0 mg/dL or less, and I don't have Gilbert's Syndrome.

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Please provide more details for an accurate summary.

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I am 18 years old or older.

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I have been on IV nutrition for at least 6 months.

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I have been diagnosed with IFALD due to ongoing high liver enzyme levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the pharmacodynamic effects of NST-6179 on hepatic cholestasis (bilirubin, ALP, GGT)

To assess the pharmacodynamic effects of NST-6179 on hepatic fibrosis (ELF, Pro-C3, FIB-4)

To assess the pharmacodynamic effects of NST-6179 on hepatic inflammation

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part B- 1200mg NST-6179Experimental Treatment1 Intervention

up to 12 subjects

Group II: Part B matched NST-6179 placeboExperimental Treatment1 Intervention

up to 6 subjects

Group III: Part A-800 mg NST-6179Experimental Treatment1 Intervention

up to 12 subjects

Group IV: Part A matched NST-6179 placeboExperimental Treatment1 Intervention

up to 6 subjects

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NorthSea Therapeutics B.V.Lead Sponsor

6 Previous Clinical Trials

552 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this clinical trial?

"The trial's sponsor, NorthSea Therapeutics B.V., needs to recruit 36 participants that satisfy the inclusion criteria in order for this medical study to be executed. These individuals will be drawn from Mayo Clinic Scottsdale Campus located in Arizona and University of California San Francisco Medical Center situated in Georgia."

Answered by AI

Is enrollment for this research still available?

"Clinicaltrials.gov attests to the fact that this experiment is currently enrolling participants, commencing on January 1st 2024 and most recently updated on December 12th 2023."

Answered by AI

How many locations are facilitating this clinical experiment?

"At present, 12 medical centres are enrolling participants for the trial. These locations range from Scottsdale to San Francisco and Atlanta with other sites also available. To reduce travel burden, it is advisable to select a clinic in close proximity when signing up for this research study."

Answered by AI

Are there adverse effects associated with Part A-800 mg NST-6179?

"Considering that it is only a Phase 2 clinical trial, with no existing data supporting efficacy but some evidence of safety, our team at Power has determined the risk level associated with Part A-800 mg NST-6179 to be a score of two."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of NST-6179 in Adult Subjects With Intestinal Failure-Associated Liver Disease (IFALD).

2024. "A Study of NST-6179 in Adult Subjects With Intestinal Failure-Associated Liver Disease (IFALD).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05919680.

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